510(k) · Cleared
ClearedTraus SIP10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saeshin Precision Co., Ltd. · EKY Handpiece, Water-Powered
Cleared on Dec 18, 2012 as substantially equivalent to K052741 (W&H Dentalwerk Buermoos GmbH, 2006) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- Dec 18, 2012
- Review
- 15 days
- Class
- Class I
- Product code
- EKY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002469 (2001). 3 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK002469 Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V)W&H Dentalwerk Buermoos GmbH · 2001
- 1 generation backK052741 Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version)…W&H Dentalwerk Buermoos GmbH · 2006
- This deviceK123695 Traus SIP10Saeshin Precision Co., Ltd. · 2012
- Descendant · cites it directly · 1 of its ownK151171 Traus SUS10Saeshin Precision Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK201292 Traus SIP20Saeshin Precision Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK192561 Traus SUS20Saeshin Precision Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK141482 KI-20Saeyang Microtech Co., Ltd. · 2015
Most influential descendants
Showing 4 of 4 · See all- K151171Traus SUS10Saeshin Precision Co., Ltd. · 2015 · cites it directly1descendant
- K201292Traus SIP20Saeshin Precision Co., Ltd. · 2021 · cites it directly0descendants
- K192561Traus SUS20Saeshin Precision Co., Ltd. · 2020 · 2 generations on0descendants
- K141482KI-20Saeyang Microtech Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002469 | Implantmed SI-95 115 (100-130 V) and SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | 2001 | — |
| −1 | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl.… | W&H Dentalwerk Buermoos GmbH | 2006 | — |
| 0 (this device) | K123695 | Traus SIP10 | Saeshin Precision Co., Ltd. | 2012 | — |
| +1 | K151171 | Traus SUS10 | Saeshin Precision Co., Ltd. | 2015 | — |
| +1 | K201292 | Traus SIP20 | Saeshin Precision Co., Ltd. | 2021 | — |
| +2 | K192561 | Traus SUS20 | Saeshin Precision Co., Ltd. | 2020 | — |
| +1 | K141482 | KI-20 | Saeyang Microtech Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EKY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. AccessoriesSummary page 1…US SIPlO Common Name - Dental handpiece and accessories Classification Name - Controller, Foot, Handpiece And Cord 3. Predicate Device: ImplantMED SI-915/923, K052741 Surgical Contra-Angle Handpiece WS-75E/KM, KO 11061 4. Classifications Names & Citations: EBW, EGS, 2 1CFR872.4200 5. D… | 2006 |
| * | K011061 | Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight… | 2001 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K151171 (Saeshin Precision Co., Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K052741.
How does its category compare?
All EKY devicesEKY Handpiece, Water-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · EKY
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · EKY
Too few EKY 510(k)s in any year since 2007 to give a median.
Recalls per year · EKY
No recall names EKY since 2007.
Adverse event reports per year · EKY
No MAUDE report names EKY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TRAUS SIP 10 is intended for use in dental surgery, implantology, maxilla-facial surgery and endodontics for treatment of dental hard tissue and mechanical rotating root canal preparation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123695 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123695: Traus SIP10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123695
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026